SBE — Digital Physical/Chemical Sterilization Process Sensor Class II
FDA product code SBE covers "Digital Physical/Chemical Sterilization Process Sensor", a Class II medical device regulated under 21 CFR 880.2801. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SBE
- Device Class
- Class II
- Regulation Number
- 880.2801
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
A digital physical/chemical sterilization process sensor is a device intended to monitor one or more parameter(s) of the sterilization process. The adequacy of the sterilization conditions as measured by the parameter(s) is/are indicated by a digital readout of the result.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230068 | 3m | 3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 1013 | May 21, 2024 |